This invention relates to a sterile strippable laminate package having therein a natural or synthetic rubber surgical glove which is lubricated with a finely divided biodegradable powder consisting essentially of an enzymatically degradable form of poly(N-acetyl-D--glucosamine) selected from the group consisting of poly[N-acetyl-6-0-(carboxymethyl)-D-glucosamine], poly[N-acetyl-6-0-(2'-hydroxyethyl)-D-glucosamine], poly[N-acetyl-6-0-(ethy)-D-glucosamine], and poly(N-acetyl -D-glucosamine) itself which form a poly(N-acetyl-D-glucosamine) is slowly enzymatically degraded by contact with body tissues. Other rubber elements which contact raw tissue may be similarly lubricated. Various dusting powders have been used on surgical gloves for years with a prime use being to facilitate insertion of the hands of operating room personnel into natural or synthetic rubber or latex gloves worn during surgery.
It is desirable that the powder on the gloves meet the following requirements:
1. It should be non-toxic to living tissue.
2. It should be biodegradable, i.e., absorbed by living tissue. This is most important since, during surgical procedures, powder almost inevitably falls or is rubbed from the surgeon's gloved hand into an exposed body cavity, and may be carried from other areas of the operating room into the exposed body cavity by air currents.
3. The powder should have no adverse effect within the body such as the creation of lesions (i.e., adhesions, granulomas, or such).
4. The glove powder must be capable of sterilization by convenient hospital techniques, preferably both autoclaving and gaseous ethylene oxide sterilization.
5. The powder must possess sufficient lubricity to permit ready insertion of the hand into the glove and must be sufficiently fine particle size and have characteristics permitting such lubricity.
6. It must be reasonably priced and readily available.
7. It must be non-irritating to skin of both the surgeon or nurse and the patient.
8. Preferably the powder resists hydrolytic degredation.
Talc was among the earliest surgical glove powders used by the medical profession. However, after the report by Antopol(Lycopodium Granuloma, Arch. Path. 16, pg. 326(1933) that talc caused granulomas in the body, the use of talc as a glove powder was rapidly abandoned. Talc was replaced by starch glove powders since starch was known to be biodegradable and was not believed to cause granulomas or other aggravating conditions within the body. Currently, a widely used commercial surgical glove powder is specially treated homogeneous amylose which contains about 2 percent magnesium oxide to prevent clumping of the powder.
However, starch glove powders have a number of disadvantages. They offer high resistance to flow and they tend to gelatinize or agglutinate in the presence of hot water thereby creating problems when they are sterilized in a steam autoclave. Ordinarily, the starch must be treated in some way to minimize these properties. For example, as shown in U.S. Pat. No. 2,626,257, the starch may be treated with an agent, such as epichlorohydrin, which partially etherifies the starch in order to make the powder free flowing after steam sterilization.
Starch is also an excellent nutrient medium for virtually all vegetative bacteria such as various pathogenic microorganisms and is objectionable for that reason.
According to Lee and Lehman(Surgery, Gynecology, and Obstetrics 84, pages 689-695(1947), starch, unlike talc, was completely absorbed within the peritoneal cavity without causing adhesions. This conclusion was challenged by Sneierson and Woo(Annals of Surgery 132, pgs. 1045-1050(1955) who reported two cases of large granulomas occurring in surgical wounds as a result of starch powder contamination. McAdams(Surgery 39, pgs. 329-336(1936) reported three cases of intraperitioneal granulomas caused by starch glove powder. The Saxens (Acta Pathology Microbiology Scand. 64, pgs. 55-70 (1965) postulated that the magnesium oxide which acts as an anticlumping material was causing the lesions. Myllarniemi and Frilander (Journal of the International College of Surgeons 44, No. 6681, pgs. 677-681 (1965) concluded that the harmful effects of starch glove powders containing magnesium oxide might be due to a combined effect of two irritating constituents. Other publications which indicate the serious concern of the medical profession over granulomas traced to starch glove powders are those of Lehman and Wilder (Journal of Abdominal Surgery 4, No. 3, pgs. 77-80 (1962), Webb and Regan (Archives of Surgery 84, No. 3, pgs. 282-285 (1962), and Walczak and Collura (American Journal of Surgery 103, No. 5, pgs. 611-612 (1962).
Despite the aforementioned disadvantages associated with starch glove powders, they are still used by the medical profession.
U.S. Pat. No. 3,728,739 - B. A. Semp. - Apr. 24, 1973 STERILE SURGICAL GLOVES shows rubber surgical elements such as tubing, catheters, drains and gloves which are lubricated with finely divided polyglycolic acid.
U.S. Pat. 3,810,458 - Semp. - May 14, 1974 MINIMIZING TISSUE REACTION TO GLOVE POWDER claims a method of minimizing tissue reaction in a surgical procedure by using a rubber surgical element having a lubricity imparting quantity of a finely divided biodegradable polymer containing hydrolytically degradable glycolic acid ester linkages.
U.S. Pat. 3,892,314 - Semp. - July 1, 1975 STERILE RUBBER GLOVE OR CATHETER PACKAGE describes sterile surgical elements in a strippable laminate container using a finely divided polyglycolic acid or related polymer as a lubricant for the surface of the rubber elements.
U.S. Pat. 3,846,382 - Ramsey and DeLapp - Nov. 5, 1974 STERILE MEDICAL DUSTING POWDER discloses a method of dissolving polyglycolic acid in hot dimethyl sulfoxide, chilling, filtering, washing with isopropanol and with recovering finely divided polyglycolic acid.
U.S. Pat. 3,632,754 - Jan. 4, 1972 - Balassa - USE OF CHITIN FOR PROMOTING WOUND HEALING teaches the application of a powder or solution of chitin or a chitin derivative to accelerate the rate of wound healing in a mammal.
Application Ser. No. 558,526 - Capozza - Mar. 14, 1975 now U.S. Pat. 3,988,411 SPINNING AND SHAPING POLY(N-ACETYL-D--GLUCOSAMINE) shows the use of exotic solvents such as hexafluoroisopropyl alcohol and hexafluoroacetone sesquihydrate in the spinning, shaping and extruding of poly(N-acetyl-D-glucosamine). Various surgical uses of the poly(N-acetyl-D-glucosamine) are taught.